UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057931 |
|---|---|
| Receipt number | R000066185 |
| Scientific Title | Observational Study on the Efficacy and Safety of Daridorexant for Insomnia Patients (Multi-center) |
| Date of disclosure of the study information | 2025/05/23 |
| Last modified on | 2026/01/05 12:06:04 |
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Basic information
Public title
Observational Study on the Efficacy and Safety of Daridorexant for Insomnia Patients (Multi-center)
Acronym
Observational Study on Daridorexant (Multi-center)
Scientific Title
Observational Study on the Efficacy and Safety of Daridorexant for Insomnia Patients (Multi-center)
Scientific Title:Acronym
Observational Study on Daridorexant (Multi-center)
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychosomatic Internal Medicine | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect improving insomnia symptoms in a real-world up to four weeks after starting daridorexant treatment, targeting insomnia patients and using the total score of the Athens Insomnia Scale (AIS) as an indicator.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in the total score of AIS from the start of daridorexant administration to the fourth week of administration.
Key secondary outcomes
Number and frequency of adverse events
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who voluntarily consented to participate in this study.
2) Patients who are 18 years of age or older at the time of consent for this study.
3) Patients diagnosed with insomnia at the research institution and who received their first administration of daridorexant 50 mg between December 2024 and May 2025.
4) Patients for whom the following data are available:
- Records confirming the diagnosis of insomnia.
- Records of the AIS at the start of daridorexant administration and at the fourth week after initiation (21 to 35 days after administration).
5) Patients with a total AIS score of 6 or higher at the start of daridorexant administration.
Key exclusion criteria
1) Patients who fall under contraindications for, or who are using daridorexant off-label.
2) Patients who are administered daridorexant in a manner inconsistent with described in the package insert.
3) Patients with a history of suicidal ideation, suicide attempts, self-harm, or drug overdose.
Target sample size
55
Research contact person
Name of lead principal investigator
| 1st name | Soichi |
| Middle name | |
| Last name | Kono |
Organization
Cosmos Street Psychosomatic Clinic
Division name
N/A
Zip code
963-0207
Address
3-69, Narugami, Koriyama City, Fukushima, 963-0207, Japan
TEL
024-962-7202
papilk-no@diary.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Kubo |
Organization
EPS Corporation
Division name
Clinical Research Center Real World Evidence Business Headquarters
Zip code
162-0814
Address
6-29, Shinogawamachi, Shinjuku-ku, Tokyo, 162-0814, Japan
TEL
03-5803-5045
Homepage URL
prj-dari-cr@eps.co.jp
Sponsor or person
Institute
Cosmos Street Psychosomatic Clinic
Institute
Department
Personal name
Funding Source
Organization
Shionogi & Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401, Mita, Minato-ku, Tokyo, 108-0073, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
コスモス通り心身医療クリニック（福島県）、ほりこし心身クリニック(福島県)、ひいらぎこころクリニック(福岡県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.cureus.com/articles/382798-real-world-effectiveness-and-safety-of-daridorexant-in-japane
Number of participants that the trial has enrolled
55
Results
Improvement in insomnia was observed up to week 4 after initiation of daridorexant treatment.
Mean change in AIS total score from baseline: minus 6.0
95% confidence interval: minus 7.2 to minus 4.8
p-value:<0.001 (statistically significant)
Participants with AIS total score 5 points or less at week 4:25 out of 54(46.3%)
Improvement was observed in all eight AIS items.
Significant improvement was also noted in participants with the following psychiatric disorders:Depression, Anxiety disorder, Schizophrenia
Results date posted
| 2026 | Year | 01 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 18 | Day |
Baseline Characteristics
Participants were required to provide voluntary consent, to be 18 years or older, to be diagnosed with insomnia, and started daridorexant 50 mg treatment. They also needed an AIS score of 6 or higher. Participants with comorbid psychiatric disorders excluded from past clinical trials were also included in this study. Participants who did not comply with the dosage and administration instructions outlined in the package insert for daridorexant were excluded.
Participant flow
This noninterventional,
observational study enrolled participants who visited one of three psychiatric clinics (Cosmos Street Psychosomatic Mental Clinic, Horikoshi Psychosomatic Clinic, or HIIRAGI Kokoro Clinic) between December 2024 and May 2025. After their visit, eligible participants who were subsequently diagnosed with insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, were initiated on daridorexant 50 mg once daily. Informed consent was obtained verbally or in writing, using a document approved by the ethics review committee, from all participants who started daridorexant as part of routine care. The existing data in their medical records were then retrieved and analyzed.
Adverse events
A total of eight adverse events occurred during the study; however, no serious adverse events were reported. Only one adverse drug reaction was observed (Malaise).
Outcome measures
The primary endpoint was the mean change in the Athens Insomnia Scale (AIS) total score from baseline to week 4 of daridorexant treatment. The other endpoints included the percentage of participants achieving an AIS total score of 5 or lower after treatment and adverse events.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 18 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 08 | Month | 31 | Day |
Other
Other related information
Safety
Management information
Registered date
| 2025 | Year | 05 | Month | 21 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066185
